IMTS Expert Perspective
Unpacking State of the Art for Clinical Evaluation Reports
The state of the art establishes the clinical context in which a medical device is evaluated. A defensible assessment connects current practice, treatment alternatives, safety and performance outcomes, and measurable acceptance criteria.
The direct answer: state of the art describes the current and generally accepted good practice in medicine and technology that is relevant to the device, its intended purpose, and the clinical condition. It may include recent advances, but it does not simply mean the newest or most technologically advanced option.
In a Clinical Evaluation Report, the state of the art is not a generic textbook introduction and it is not a catalogue of competing products. It is the evidence based clinical reference point used to understand the disease, the available treatments, the expected benefits and risks, and the outcomes against which the subject device should be evaluated.
This makes the state of the art central to the clinical evaluation. It helps the manufacturer explain whether the device achieves clinically meaningful performance, whether its risks and undesirable side effects remain acceptable, and whether the claimed clinical benefits are supported in the context of current practice.
A structured clinical story
Move from the condition to the benchmark.
A useful state of the art assessment usually begins broadly and becomes progressively more specific. The scope must remain tied to the intended purpose, indications, target population, users, anatomical sites, and relevant device characteristics.
- 01
Background on the condition
Define the disease or condition, epidemiology, diagnosis, prognosis, natural history, burden of disease, and the needs of the intended patient population.
- 02
Current treatments and alternatives
Describe accepted treatment options from conservative management through more invasive interventions, including relevant medical devices and no-treatment options where appropriate.
- 03
Safety and performance outcomes
Identify the clinically meaningful parameters used to evaluate benefits, risks, performance, complications, and undesirable side effects across the current treatment landscape.
- 04
Acceptance criteria
Translate the evidence into justified, measurable thresholds or ranges against which the subject device can be evaluated.
- 05
Synthesis and conclusion
Summarize what is generally accepted in current clinical practice and explain the benchmarks that are relevant to the device, its intended purpose, and its claims.
When the device addresses more than one condition, indication, or patient group, each relevant area should receive enough attention to support the corresponding claim. A brief discussion of one indication cannot automatically serve as the clinical context for another.
| Evidence source | Contribution to the state of the art |
|---|---|
| Clinical practice guidelines | Define accepted care pathways, treatment recommendations, patient selection, and recognized clinical outcomes. |
| Systematic reviews and high quality studies | Characterize benefits, risks, comparative outcomes, limitations, and areas of uncertainty. |
| Standards and regulatory guidance | Identify current technical and clinical expectations that apply to the device and evaluation. |
| Comparable devices and alternative treatments | Provide direct and indirect context for the device without treating commercial availability alone as proof of clinical acceptance. |
| Registries and real world evidence | Help describe contemporary outcomes, uncommon events, long term experience, and actual patterns of care when the data are fit for purpose. |
Safety, performance, and clinical benefit
Outcomes should lead to justified acceptance criteria.
Safety and performance outcomes are the specific, measurable parameters used to evaluate the benefit and risk profile for the indications and intended purpose of the device. Their relevance depends on the medical condition, treatment pathway, device technology, expected clinical benefit, and known complications.
A performance outcome might address technical success, treatment success, functional improvement, diagnostic accuracy, or another measure that reflects the device's intended purpose. A safety outcome might address infection, bleeding, hypoglycemia, device related adverse events, reintervention, or another clinically relevant complication. Each selected outcome should be justified.
Acceptance criteria convert the state of the art from background information into an evaluative framework for the subject device.
Acceptance criteria should be specific and measurable. They may be expressed as a threshold, range, rate, or other justified parameter. The supporting rationale can draw from current literature, relevant clinical studies, recognized standards, and appropriate manufacturer data. The derivation should be transparent, reproducible, and suitable for the clinical question.
A numerical value should not be selected merely because it appears in one publication. Differences in population, follow up, endpoint definitions, device generation, operator experience, and study design can make apparently similar rates unsuitable for direct comparison. The CER should explain how the evidence was synthesized and why the proposed criterion is clinically and scientifically defensible.
A practical development method
Build the assessment through a transparent evidence process.
Define the clinical question
Start with the intended purpose, target population, indications, contraindications, clinical benefits, claims, and known risks. These elements determine which current practices and outcomes are relevant.
Plan a traceable literature search
Use a documented search strategy that covers the condition, current interventions, comparable devices, clinical outcomes, safety events, standards, and guidance. Record databases, dates, terms, limits, and selection criteria.
Appraise and synthesize the evidence
Assess relevance, methodological quality, applicability, consistency, and limitations. Separate accepted practice from emerging practice and explain important disagreement in the evidence.
Compare the subject device
Use the resulting outcomes and benchmarks to evaluate the device's safety, performance, clinical benefits, residual risks, and evidence gaps. Carry the conclusions into PMCF and risk management where needed.
The state of the art should be reviewed throughout the device lifecycle. New guidelines, therapies, devices, evidence, safety signals, or changes in clinical practice may alter the relevant benchmarks and can affect the CER, risk management, labeling, PMS, PMCF, PSUR, and SSCP.
Common weaknesses
What makes a state of the art assessment difficult to defend?
- Treating state of the art as a short disease overview with no connection to device evaluation.
- Assuming the newest technology automatically represents generally accepted clinical practice.
- Using competitor labeling or marketing materials as the primary evidence base.
- Listing treatment options without comparing their benefits, risks, outcomes, limitations, and place in the care pathway.
- Selecting outcomes or acceptance criteria without a documented clinical and statistical rationale.
- Applying literature from a different population, indication, follow up period, or endpoint definition without discussing applicability.
- Failing to update the assessment when current practice or the available evidence changes.
A strong assessment allows a reviewer to trace each important conclusion back to the evidence and forward to the device evaluation. The search, appraisal, synthesis, outcomes, and acceptance criteria should form one coherent chain of reasoning.
Primary regulatory references